NCT05074108

Brief Summary

Despite documented evidence of disordered eating (DE) among Active Duty (AD) Service Members (SM) and Veterans, DE has not been assessed in SM undergoing the transition from AD to Veterans status (AD-VS). The objective of the current study is to explore gender differences and associations between nutrition knowledge, DE attitudes and behaviors, mental health, and military-specific experiences in women and men undergoing the AD-VS transition, and then use this information along with qualitative feedback from focus groups to inform adaptations of an existing nutrition education program for pilot testing in AD-VS women and men.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 23, 2024

Status Verified

August 1, 2021

Enrollment Period

2.4 years

First QC Date

August 9, 2021

Last Update Submit

April 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Nutrition knowledge

    Scores on Abridged Nutrition for Sport Knowledge Questionnaire. Questionnaire is 35 questions long. Answers are scored as either correct or incorrect. Scores range from 0-35, higher scores are more desirable and indicate greater nutrition knowledge.

    Pre and Post intervention, approximately 6 weeks apart

  • Eating attitudes / behaviors

    Scores on Eating Pathology Symptoms Inventory. The Eating Pathology Symptoms Inventory (EPSI) is a self-report questionnaire that includes 45 items covering 8 subscales: Body Dissatisfaction, Binge Eating, Cognitive Restraint, Purging, Restricting, Excessive Exercise, Negative Attitudes toward Obesity, and Muscle Building. Each item is scored on a 5-point Likert-style scale (0 = Never; 4= Often) to describe how well each item describes the participant's experiences. Scores are derived by summing responses across the questions included in each subscale. Scores range from 0-180. Lower scores are more desirable.

    Pre and Post intervention, approximately 6 weeks apart

  • Eating attitudes / behaviors

    Scores on Eating Disorder Examination-Questionnaire Short. The Eating Disorder Examination - Questionnaire Short (EDE-QS) was developed as a 12-item version of the Eating Disorder Examination Questionnaire (EDE-Q) with a 4-point response scale that assesses eating disorder (ED) symptoms over the preceding 7 days. Scores range from 0-36. Lower scores are more desirable.

    Pre and Post intervention, approximately 6 weeks apart

Study Arms (1)

Pilot study

EXPERIMENTAL

Adapt and pilot a nutrition-based intervention. The program will take a holistic approach to educate participants about basic nutrition and cooking skills, sleep, and mindfulness strategies to enhance mental health.

Behavioral: Pilot study

Interventions

Pilot studyBEHAVIORAL

Aiming for an interaction 6 week course that will discuss many aspects of health and wellness.

Pilot study

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Current Active Duty Service Member in the process of transitioning (e.g. separating or retiring) from the military assigned to Naval Support Activity Bethesda
  • Age ≥17 years old
  • Read and write English

You may not qualify if:

  • Self-reported current or recent (past 5 years) diagnosis of a Diagnostic and Statistical Manual- (DSM-5) eating disorder including: Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder AND/OR
  • A score of ≥15 on the Eating Disorder Examination-Questionnaire Short (EDE-QS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Interventions

Pilot Projects

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jonathan M Scott, PhD

    Uniformed Services University of the Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

October 12, 2021

Study Start

January 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

April 23, 2024

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Data generated under the funding award will be provided to the Military Women's Health Research Consortium and the Uniformed Services University, as requested in the Funding Opportunity Announcement. More broadly, data will be shared in an aggregated form through abstracts and presentations submitted to research conferences and manuscripts written for publication in peer-reviewed scientific journals. To protect the confidentiality of the participants, no data will ever be identified in publications/presentations.